570  Practice Settings–Guidelines
ASHP Guidelines on
Home Infusion Pharmacy Services
Background and Purpose
Background. Home infusion services are provided by a va-
riety of organizations, including hospitals, community phar-
macies, home health agencies, hospices, and specialized
infusion companies. Patients receive care in non-inpatient
settings, such as their homes and ambulatory infusion cen-
ters, or in alternative-site settings, such as skilled-nursing
facilities. Home infusion pharmacies may provide one or
more of several service lines:
• Infusion therapies (e.g., intravenous, subcutaneous,
intrathecal, epidural);
• Specialty pharmacy services;
• Ambulatory infusion center services;
• Home health nursing;
• Private duty nursing;
• Respiratory equipment and clinical respiratory services;
• Hospice services;
• Home medical equipment and supplies (with or with-
out oxygen service); or
• Enteral products and supplies.
It should be noted that different aspects of home infusion
can be provided by different organizations. When services
are shared among providers, pharmacists have a professional
responsibility to ensure that all patient care responsibilities
are defined, understood, agreed upon, coordinated, and doc-
umented in advance by all providers. These guidelines apply
to the provision of home infusion services by pharmacists
practicing in all health care settings.
Purpose. The purposes of these guidelines are to define the
role of the pharmacist in providing home infusion care to
patients and to outline minimum requirements (indicated by
use of the word “shall”) and best practices for the operation
and management of services provided by pharmacies in the
home or alternative-site setting. In broad terms, home in-
fusion includes the provision of specialized, complex phar-
maceutical products; development and execution of plans
to manage the medication therapy of patients; and clinical
assessment and monitoring of patients in their homes. These
services generally include home infusion therapy; other
injectable drug therapy; parenteral and enteral nutrition
therapy; and occasionally preparation of other sterile prepa-
rations, compounds, or products. As the number and types
of therapies administered in the home and alternative sites
expand, the resources and support required to provide these
therapies will expand as well. Specific and unique pharma-
cist education and training in drug product admixtures and
administration techniques, equipment operation and mainte-
nance, patient monitoring, and patient and family education
are required to ensure successful outcomes. These guidelines
outline the pharmacist’s role in providing these services and
products. They are not intended to apply to home health or
previously mentioned services that do not involve the provi-
sion of home infusion pharmacy services.
Many of the activities included in these guidelines are
the subjects of other American Society of Health-System
Pharmacists (ASHP) policy and guidance documents, which
should be referred to for additional information. Pharmacists
practicing in home infusion should use professional judg-
ment in assessing ASHP’s policy and guidance documents
and in adapting them to meet their health care organizations’
and patients’ needs and circumstances.
To ensure the safe, appropriate, and effective use of
medications in the home, home infusion pharmacies should
develop comprehensive services to address factors unique
to home infusion. Caregivers such as family members, who
often have no health care experience, should be trained if
deemed safe and appropriate to properly administer, store,
and dispose of medications supplies and biohazard waste;
operate medication administration devices; and monitor pa-
tients as necessary. Many medications must be aseptically
compounded, often in quantities sufficient for a week’s use,
and delivered under conditions that will ensure that prod-
uct potency and purity are maintained. Vascular access for
infused therapies should be maintained for the intended du-
ration of treatment, which may range from days to years.
Medication administration devices should be selected and
maintained to accurately and safely administer a variety of
therapeutic regimens. Potential complications should be an-
ticipated, and a proactive individualized plan of care should
be established for monitoring, detecting, and managing com-
plications, including those related to equipment, enteral and
parenteral access, compliance, response to therapy, and pa-
tient and family education. Economic considerations should
be taken into account so that care is provided in the most
cost-effective manner. Home infusion pharmacies should
have an effective organizational structure with the flexibility
to meet the changing needs of patients, as well as to keep
pace with the rapid growth of the industry and changes in
health systems. As health care providers in the home setting,
pharmacists must be concerned with the outcomes of ther-
apy and not just the provision of services. Effective manage-
ment is necessary to ensure that quality outcomes of therapy
are achieved. While the scope of pharmacy services is likely
to vary from site to site, depending upon the needs of the
patients served, these criteria are strongly linked to patient
outcomes; neglect of any one area may compromise quality.
Practice Management
Mission and Goals of the Home Infusion Organization.
The pharmacy or its affiliated organization shall have a
written mission statement that reflects patient safety, qual-
ity of care, and operational responsibilities. The statement
should be consistent with the mission of the parent home
infusion organization and/or health system, if applicable.
The development and prioritization of goals, objectives, and
work plans shall be consistent with the pharmacy’s mission
statement. The mission should be understood by employees,
contract staff, and other participants (e.g., students and resi-
dents) in the pharmacy’s activities.

Laws and Regulations. The home infusion pharmacy shall
comply with all applicable local, state, and federal laws and
regulations. Laws and regulations change frequently, so it is
imperative to remain up to date on these changes so that the
pharmacy remains in compliance. The pharmacy shall main-
tain written or computerized documentation of compliance
regarding procurement, storage, and distribution of drug prod-
ucts, patient information, and related safety regulations from
applicable state boards of pharmacy, the federal Food and Drug
Administration (FDA), the United States Pharmacopeia (USP),
the Drug Enforcement Administration (DEA), the Centers
for Medicare & Medicaid Services (CMS), the Occupational
Safety and Health Administration (OSHA), the National
Institute for Occupational Safety and Health (NIOSH), and
the Environmental Protection Agency (EPA), among others.
Pharmacy management of patient information shall conform
to the Health Insurance Portability and Accountability Act of
19961 (HIPAA) and to the parent organization’s policies and
procedures. Pharmacies that participate in Medicare Part D
plans shall comply with government regulations for Medicare
Part D, which may include annual compliance training regard-
ing Medicare fraud and abuse. Appropriate business licenses,
permits, and tax stamps should also be available.
Licensure. Professional staff shall maintain pharmacist li-
censure applicable to their practice. Policies and procedures
should be available to ensure that health care providers meet
applicable state licensure and home infusion organization
authorization, if required, for prescribing medications.
Many states require pharmacies with out-of-state phar-
macy licenses to also have a pharmacist licensed in the state
of the prescription recipient. Pharmacies dispensing drugs
across state lines shall comply with out-of-state licensure
requirements, as well as other state and federal interstate
laws and regulations. The pharmacy director shall have a
process in place for validating current licensure of all pro-
fessional staff, and the source(s) of this validation shall also
be verified. In locations in which pharmacy technicians are
required to be registered and/or certified, such registration
and/or certification shall be validated annually or as required
by law or regulation.
Accreditation. Accreditation provides patients, referral
sources, and payers the assurance that the pharmacy meets
a basic level of quality in patient care. Accreditation may be
required by some payers and is recommended for the home
infusion pharmacy. Accrediting bodies may include the Joint
Commission, Community Health Accreditation Program
(CHAP), Pharmacy Compounding Accreditation Board
(PCAB), Healthcare Quality Association on Accreditation
(HQAA), Accreditation Commission for Healthcare
(ACHC), and Medicare.
Practice Standards and Guidelines. Appropriate practice
standards and guidelines of professional pharmacy orga-
nizations such as ASHP should be assessed and utilized as
appropriate to the scope of pharmacy services provided.
The standards of other professional clinical organizations,
such as the American Society for Parenteral and Enteral
Nutrition (A.S.P.E.N.), the Infusion Nurses Society (INS),
the Infectious Diseases Society of America (IDSA), and the
Oncology Nursing Society (ONS), should also be assessed
and used when applicable to the home infusion organiza-
Practice Settings–Guidelines  571
tion, its scope of services, and the population served. Such
practice standards and guidelines should be adapted into the
organization’s policies and procedures when appropriate.
Policies and Procedures Manual. A policies and procedures
manual governing the scope of the home infusion pharmacy
services (e.g., administrative, operational, clinical, quality
performance and/or improvement, infection control, drug
preparation and dispensing, equipment maintenance) shall
be properly maintained and available. The manual should
be reviewed and revised annually or whenever necessary
to reflect changes in procedures specific to the sites where
the pharmacy’s products and services are provided. All per-
sonnel should be familiar with the contents of the manual.
Appropriate mechanisms should be established to ensure
compliance with the policies and procedures.
Human Resources
The responsibilities and related competencies for home infu-
sion pharmacy employees should be clearly defined in writ-
ten position descriptions for all job categories.
Director of Home Infusion Pharmacy Services. Effective
leadership and practice management skills are necessary for
pharmacists’ delivery of care that meets the needs of patients
and the health system and results in continuous improvement
in patient outcomes. These guidelines use the term director
of home infusion pharmacy services (or, more simply, direc-
tor) to indicate the person responsible for managing those
services. Depending on the health system’s organizational
structure and other factors, designations such as manager or
pharmacist-in-charge may also be used.
The director of the home infusion pharmacy services
must work in collaboration with appropriate health-system
leaders to create a long-term vision for the home infusion
pharmacy department that is consistent with that of the
health system. Depending on the size and scope of the set-
ting, these functional responsibilities may be assigned to a
single person or a team. It is the responsibility of the director
to monitor the status of the goals set forth in the department’s
vision, provide feedback to the pharmacy team as necessary,
and support the team’s implementation of the core functions
of the pharmacy practice.
Home infusion pharmacy services should be managed
by a professionally competent, legally qualified pharmacist.
In addition to the requirements for a staff pharmacist, the
director shall be thoroughly knowledgeable about home in-
fusion pharmacy practice and management. Completion of a
pharmacy residency program and/or home infusion experi-
ence is desirable.
The director shall be responsible for
• Establishing the mission, vision, goals, and scope of
services of the pharmacy on the basis of the needs of
the patients served, the needs of the health system, and
developments and trends in health care;
• Developing, implementing, evaluating, and updating
plans and activities to fulfill the mission, vision, goals,
and scope of services of the pharmacy;
• Ensuring the development and implementation of
policies and procedures that provide safe and effective
medication use for the patients served by the institution;
572  Practice Settings–Guidelines
• Mobilizing and managing the resources, both human
and financial, necessary for the optimal provision of
pharmacy services;
• Overseeing contracts (for example vendors, home
health agencies, payers, etc.);
• Ensuring that pharmacy services are delivered in com-
pliance with applicable state and federal laws and reg-
ulations, as well as national practice standards; and
• Ensuring all technology and automation used through-
out the medication use process is implemented, main-
tained, and utilized to promote patient safety.
A part-time or contract director shall have the same obliga-
tions and responsibilities as a full-time director. The direc-
tor, in carrying out these responsibilities, should supervise
an adequate number of competent, qualified personnel.
Home Infusion Pharmacists. Pharmacists who provide
home infusion services shall have an active license to practice
pharmacy issued by the applicable state board of pharmacy
and other credentials as required by local, state, or federal
laws and regulations. Some states require special licensure
or training for preparing sterile preparations. Pharmacists
dispensing medications to patients who reside in other states
may also be subject to laws and regulations in those states;
additional licensure may be required. The pharmacist should
be knowledgeable about all applicable federal and state laws
and regulations. The pharmacist is responsible for:
• Day-to-day supervision of dispensing sterile prepara-
tions and delivery activities;
• Drug information provided to nurses, physicians, pa-
tients, and caregivers;
• Clinical monitoring, care planning, and assessment of
home infusion patients;
• Maintaining a professional image and demeanor in
both appearance and actions;
• Maximizing work efficiency and patient safety through
the use of technology;
• Maintaining confidentiality of patient and proprietary
information; and
• Utilizing support personnel effectively.
Technicians and Other Support or Clinical Staff. Sufficient
support personnel (pharmacy technicians, clinical staff [e.g.,
nurses, dietitians, respiratory therapists], and customer ser-
vice, procurement, delivery, clerical, and administrative
personnel) should be available to facilitate the delivery of
home infusion pharmacist care and services. Pharmacy tech-
nicians should have completed an accredited pharmacy tech-
nician training program and be certified by the Pharmacy
Technician Certification Board (PTCB). The pharmacy
should hire pharmacy technician trainees without those
qualifications only if those individuals (1) are required to
both successfully complete an accredited pharmacy techni-
cian training program and successfully complete PTCB cer-
tification within 12 months of employment or as required by
law or regulation, and (2) are limited to positions with lesser
responsibilities until they successfully complete such train-
ing and certification. The pharmacy should require ongoing
PTCB certification as a condition of continued employment.
Appropriate supervisory controls should be maintained and
documented, consistent with federal and state laws and reg-
ulations. In states in which registration of pharmacy tech-
nicians and/or special licensure or training is required for
specific responsibilities (e.g., preparing sterile preparations),
the pharmacy shall ensure that such requirements are met.
Pharmacy technicians are responsible for compound-
ing sterile and nonsterile preparations in a manner to en-
sure patient safety, managing drug inventory, contacting
patients about scheduled deliveries, and other duties as as-
signed. Customer service staff may be tasked with contact-
ing patients about scheduled deliveries, communication with
customers (e.g., other suppliers, patients, families, referral
sources), and other duties as assigned. Drivers and/or ware-
house managers may be responsible for delivery of medi-
cation to the patient, processing of initial paperwork to be
signed, storage of medication in the home, observation of
quantities of medications and supplies left in the home, and/
or communication with the pharmacist if there are any ques-
tions or concerns. Intake personnel, insurance verification
staff, and/or billers take referrals, determine insurance cov-
erage, obtain authorizations or precertifications and renew
them as needed, bill payers for services provided, and follow
up on rejected claims.
Staffing, Work Schedules, and Assignments. The director
should ensure that work schedules, procedures, and assign-
ments make the best use of pharmacy personnel and other
resources. Resources should be sufficient to ensure patient
safety. Flex time, weekend options, exempt and nonexempt
status, shift differentials, and on-call pay and responsibilities
should all be considered when creating a staffing plan.
Recruitment and Selection of Personnel. Personnel should
be recruited and selected on the basis of the requirements
stated in the established job description, the candidates’
job-related qualifications, and their prior performance. The
pharmacy director should assist in identifying the relevant
professional and technical qualifications for each job de-
scription and should participate in candidate interviews
and final selection. The organization should have a human
resources manual stating the requirements for reference
checks, criminal background checks, and primary source
verification of professional licenses. In addition, it should be
organization policy that the Office of the Inspector General
(OIG) List of Excluded Individuals/Entitites2 is checked
to ensure that potential candidates for employment have
not been excluded from federally funded health care pro-
grams. Employees’ professional licenses and the OIG List
of Excluded Individuals/Entities should be verified at least
annually.
Recruitment for home infusion pharmacy positions
can be a challenge, especially when the pharmacist la-
bor market is tight. Home infusion pharmacy practice is a
unique practice setting with which many pharmacists are
not familiar, especially new graduates. Infusion pharmacy
practice training in college of pharmacy curricula varies,
so recruiting staff with home infusion experience may not
be possible. Creative recruitment techniques, such as hiring
part-time pharmacists to cover open positions and offering
on-site training, may help recruitment.
Orientation and Training. All employees shall be oriented
to the type(s) of care and services provided by the organiza-
tion. There should be an established procedure for orienting

new personnel to the pharmacy, the parent organization, the
health system(s) that the home infusion pharmacy serves, re-
spective staff positions, and the patient populations served.
All employees should understand the roles and responsibili-
ties of others in the organization and should be oriented and
demonstrate proficiency on equipment they are expected to
operate or support as part of their duties. Employees should
be knowledgeable about the supplies and equipment that are
delivered to the patient. All personnel should possess the
education and training needed to fulfill their responsibilities,
including specific knowledge related to home infusion. All
personnel should participate in continuing education pro-
grams and activities relevant to home infusion practice as
necessary to maintain or enhance their competence.3
A home infusion organization is responsible for help-
ing teach employees, patients, family members, and care-
givers about standard safety precautions. The pharmacist
should ensure that the home infusion organization provides
appropriate education for its employees and patients, in-
cluding education about appropriate disposal and handling
of medical waste, procedures for preventing and manag-
ing needle and sharps stick injuries,4 handling of cytotoxic
and hazardous medications,5 and material safety data sheets
(MSDSes).6 The pharmacist should be a key resource in the
development of such educational programs. The pharmacist
should assume an active role in the home infusion organiza-
tion’s infection-control activities.
Pharmacists should receive training as necessary to
ensure that they possess the knowledge and skills required
for the provision of home infusion services. They should
participate in ongoing continuing education activities to up-
date and enhance their knowledge and skills related to home
infusion. Pharmacists should also participate in an ongoing
competence assessment program as part of an overall staff
development program. A valid assessment of competence
should consider the pharmacist’s responsibilities and the
types and ages of patients served. The assessment should
be conducted and documented on an ongoing basis for all
pharmacists. When appropriate, pharmacists should assist
in training and in continuing education programs for other
home infusion providers.
Performance Evaluation, Contribution Management, and
Competency Assessment. Policies and procedures should
define the ongoing performance evaluations, contribution
management, and competency assessments of home infusion
pharmacy personnel. All home infusion pharmacy personnel
should receive regular and timely evaluations. Performance
should be evaluated on the basis of position description re-
quirements and expected competencies. ASHP guidelines7
and USP Chapter 7978 describe requirements for initial and
ongoing assessment of compounding knowledge and skills.
Competency assessments should include practical skills (e.g.,
aseptic technique challenge), clinical competencies (e.g., as-
sessing patients, developing a plan to manage patient care,
and executing the plan), equipment competencies, and patient
teaching competencies, if appropriate (i.e., if the employee
will be instructing patients). Monitoring clinical outcomes is
a critical part of the home infusion pharmacist’s roles.
Practice Settings–Guidelines  573
Financial Management
Budget Management. The home infusion pharmacy should
have a budget that is consistent with the health system’s fi-
nancial management process and supports the scope of and
demand for pharmacy services. Oversight of workload and
financial performance should be managed in accordance
with the health system’s requirements. Management should
provide for the determination and analysis of pharmacy ser-
vice costs, the determination and analysis of capital equip-
ment costs, and the determination and analysis of new proj-
ect growth.
The pharmacy budget processes should enable the
analysis of pharmacy services by unit of service and other
parameters appropriate to the organization (e.g., organiza-
tion-wide costs by medication therapy, clinical service, spe-
cific disease management categories, and patient third-party
enrollment). The director should have an integral part in the
organization’s financial management process.
Health-System Integration. Other functional units within
the health system should factor the cost of pharmacy ser-
vices being provided by the home infusion pharmacy into
their departmental budget when appropriate.
Third-Party Contract Review. In conjunction with the or-
ganization’s legal department, the pharmacy director’s team
should review third-party payer contracts to ensure that re-
imbursement is appropriate for services being rendered and
that terms of the contracts are in the best interests of the
patient and the health system. The pharmacy should contract
with third-party payers that are relevant to the pharmacy’s
patient population.
Drug and Supply Expenditures. Specific policies and pro-
cedures for managing drug expenditures should address
such methods as competitive bidding, group purchasing, uti-
lization review programs, inventory management, and cost-
effective patient services.
Manufacturers and Suppliers. Criteria for selecting drug
product manufacturers and suppliers should be established
by the pharmacy to ensure the quality of drug products and
the best prices, and that vendors are able to supply products
in the volume required.
Reimbursement. The director of the pharmacy or home infu-
sion organization should be knowledgeable about reimburse-
ments for home infusion pharmaceutical services, medica-
tions, supplies, durable medical equipment, and, if applicable,
nursing services. Processes should exist for routine verifica-
tion of patient reimbursement benefits and for counseling
patients about their anticipated financial responsibility for
planned therapies. A process should also exist for responding
to service requests from medically indigent patients.
The director of the pharmacy or home infusion organi-
zation should also be responsible for policies regarding drug
procurement, drug expenditures, inventory management,
determination and analysis of pharmacy service costs, capi-
tal equipment acquisition, budgeting (including analysis of
budgetary variances, patient revenue projections, and justifi-
cation of personnel commensurate with workload productiv-
ity), and payer audits.
574  Practice Settings–Guidelines
Medication Use and
Drug Information Services
Medication-Use Policy Development. Medication-use
policy decisions should be founded on the evidence-based
clinical, ethical, legal, social, philosophical, quality-of-life,
safety, and economic factors that result in optimal patient
care. Committees within the organization (e.g., pharmacy
and therapeutics, infection control) that make decisions con-
cerning medication use should include the active and direct
involvement of physicians, pharmacists, and other appropri-
ate health care professionals. The pharmacy should actively
participate on committees whose decisions could affect the
quality, safety, effectiveness, or cost of pharmacy services or
the medication-use process.
Medication Therapy Decisions. The pharmacist’s preroga-
tives to initiate, monitor, and modify medication therapy for
individual patients, consistent with laws, regulations, home
infusion organization policy, and clinical protocols, should
be clearly delineated and approved by the home infusion or-
ganization’s authorized leadership.
Formulary. An independent home infusion provider does
not have to abide by a formulary; drugs are dispensed ac-
cording to the orders of the physicians in its service area.
A hospital- or health-system-based infusion pharmacy may
have to abide by the same formulary restrictions as the rest
of the hospital or health system. The home infusion phar-
macist should have a mechanism for providing input to the
formulary committee.9 The pharmacy should have access to
specialty medications distributed through closed network
systems when needed to support consistent delivery of pa-
tient care and medication reconciliation.
Selection of Medications. Policies and procedures address-
ing the selection of medications should be available. These
policies should be based on clinical appropriateness and
USP standards. For bulk powders, USP or chemical stan-
dards for purity should be applied. Selection criteria should
also include safety (including clinical and labeling safety
such as manufacturer use of “tall man” lettering), efficacy,
and ability to detect counterfeit medications.
Drug Information. The home infusion pharmacist should
provide accurate, comprehensive, and patient-specific drug
information to patients, caregivers, other pharmacists, physi-
cians, nurses, and other health care providers as appropriate,
both proactively and in response to requests associated with
the delivery of pharmacy patient care, educational programs,
and publications. Pharmacists should provide concise, ap-
plicable, and timely responses to requests for drug informa-
tion from health care providers and home infusion patients.
Responses to general and patient-specific drug information
requests should be accurate and prompt. Drug information
requests and responses should be documented and monitored
for accuracy and timeliness as part of performance improve-
ment activities. Policies and procedures should be in place
for reviewing responses to requests for drug information for
the purpose of performance improvement and education.
Adequate information about a medication’s thera-
peutic use, dosage, potential adverse effects, and safe ad-
ministration in the home, including storage and stability
requirements, should be supplied before the medication is
administered. Information about the stability of drugs for
home infusion should address administration via a variety
of alternative delivery devices, such as portable infusion
pumps, syringe pumps, implantable infusion devices, elasto-
meric infusion pumps, and common peripheral and central-
line administration devices.
Adequate space, resources, and information handling
and communication technology shall be available to facili-
tate the provision of drug and related information to patients,
caregivers, health care providers, multidisciplinary team
members, and referring physicians. The director shall iden-
tify a core library (hard copy or electronic) appropriate for
a home infusion pharmacy practice setting and ensure that
those resources are readily available to users. Drug informa-
tion sources should include current professional and scien-
tific periodicals, Web-based research tools (e.g., AHFS-DI,
MicroMedex, Lexi-Comp Online), the latest editions of drug
compendia and textbooks in appropriate pharmaceutical and
biomedical subject areas, and any references required by
state boards of pharmacy. Availability of drug information
on electronic media is desirable. Information may be ac-
cessed and provided in conjunction with medical libraries
and other resources.
Available information sources should support research
on patient care issues, facilitate provision of patient care,
and promote safety in the medication-use process. When
possible, a pharmacist should have a role within the health
system for addressing complex drug information questions
presented by professional staff (e.g., pharmacists, nurses,
physicians).
If applicable, pharmacists should have access to in-
formation on all investigational studies and similar research
projects involving medications and medication-related
devices used by the organization. Pharmacists should, fol-
lowing the organization’s procedures, provide pertinent
written information (to the extent known) about the safe
and proper use of investigational drugs, including possible
adverse effects, to family members, nurses, pharmacists,
physicians, and other health care providers involved in the
care of patients admitted to the investigational drug proto-
cols. Pharmacist representation on the health system’s insti-
tutional review board is preferred.10,11
Education and Mentoring of Staff, Students, and Providers.
The home infusion pharmacy staff should provide in-service
education to physicians, nurses, pharmacy technicians,
and other practitioners on home infusion pharmacy-related
issues. They should also provide, to the extent possible in
their organizations, student experiential education, extern-
ship, and internship training, as well as postgraduate resi-
dency training. Home infusion pharmacy staff also have a
responsibility to keep the home infusion organization’s staff
informed about the use of medications on an ongoing basis
through appropriate consultations, publications, and presen-
tations. Pharmacists should ensure the timely dissemination
of drug product recall notices, safety alerts, market with-
drawals, and labeling changes.
Administration Devices, Delivery Systems, and Automated
Dispensing Devices. Home infusion pharmacists should
provide leadership and advice in organizational and clini-
cal decisions about the selection of drug delivery systems,

administration devices, and automated compounding and
dispensing devices, and should participate in the evaluation,
use, and monitoring of these systems and devices.12 The po-
tential for medication errors associated with such systems
and devices should be thoroughly evaluated. Policies and
procedures should be available for the certification (calibra-
tion) and maintenance of equipment and devices. Equipment
should be adequately maintained and certified in compliance
with applicable standards, laws, and regulations. Equipment
maintenance and certification should be documented.
Preventive and Postexposure Immunization Programs.
The pharmacy should participate in the development of poli-
cies and procedures concerning preventive and postexposure
programs for infectious diseases (including, but not limited
to, human immunodeficiency virus infection, tuberculosis,
and hepatitis) for patients and employees.
Substance Abuse Programs. The pharmacy should assist
in the development of, and participate in, substance abuse
prevention, education, and employee and patient assistance
programs.13
Development of Patient Care Services. The home infusion
pharmacy services team should be involved in the develop-
ment, implementation, and evaluation of new or changing
patient care services within the organization, such as the de-
velopment of new clinic sites or new service areas or lines.
In reviewing the potential for new services, both the value
added to patient care by the new service and the financial
and logistical implications of the new service should be con-
sidered. These efforts should promote the continuity of phar-
macist patient care across the continuum of care, practice
settings, and geographically dispersed facilities.
Committee Involvement. The director and other pharmacy
staff should contribute to the organization’s goals through
effectively participating in or leading committees and infor-
mal work groups. The pharmacist should be involved in the
home infusion organization’s initiatives to develop model
clinical protocols and assessments that develop pharmacist
care plans, pathways, or disease management guidelines to
ensure that pharmacist care elements are included.14 Clinical
protocols should be used whenever appropriate to maximize
the safety of medication use in the home.
A pharmacist should be a member of and actively par-
ticipate on committees responsible for establishing policies
and procedures for medication use, patient care, and per-
formance improvement, among other things.9 Pharmacists
should also participate in the activities of similar committees
of a parent home infusion organization or health system, as
applicable.
The director or a designee should be a member of the
home infusion organization’s or health system’s institutional
review board, if applicable.
Drug Procurement and Management
The home infusion pharmacy should be responsible for the
proper acquisition, compounding, dispensing, storage, deliv-
ery, and administration of all drug products used in the treat-
ment of the organization’s patients, as well as the proper use
of related equipment and supplies. Policies and procedures
Practice Settings–Guidelines  575
governing medication procurement and management should
be developed by the pharmacy in collaboration with other
appropriate organization staff and committees.
Selection of Medications and Management of Supplies
and Inventory. Policies and procedures governing selection
of medications and management of supplies and inventory
should be developed by the pharmacy director in collabora-
tion with other appropriate home infusion organization staff
members.
Procurement through Wholesalers, Manufacturers, or
Group Purchasing Organizations. Each pharmacy should
have a primary drug wholesaler for routine stock orders and
a local source (e.g., a local hospital) for obtaining medica-
tions it does not have in stock. Group purchasing organiza-
tions (GPOs) may be used to control purchasing costs for
drugs and supplies. Policies and procedures should address
procurement and management of medications that must be
obtained directly from the manufacturer or a limited set of
distributors to ensure safe and proper pedigree of pharma-
ceutical products.15,16
Storage and Stock Levels. Each pharmacy should determine
the appropriate level of stock required to serve the local pa-
tient population and manage its physical inventory for maxi-
mum cost control and operational efficiency.
Returns, Recalls, and Backorders. Procedures should be in
place for responding to drug and device product returns, re-
calls, and backorders; for identifying patients who received
or used a recalled product; and for removing the drug or de-
vice product from the pharmacy or home when the recall is
at the user level. All stocks of medications stored in the home
infusion pharmacy or in the organization’s facilities should
be inspected routinely to ensure the absence of recalled, out-
dated, unusable, or mislabeled products. Inspections should
include identification of storage conditions that could com-
promise medication integrity, storage arrangements that
might contribute to medication errors, and storage locations
that might be vulnerable to drug diversion efforts.
Drug Shortages. There shall be policies and procedures
for managing drug product shortages. The pharmacy’s in-
ventory management system should be designed to detect
subminimum inventory levels and alert the pharmacy to po-
tential shortages, and pharmacy staff should monitor reliable
sources of information regarding drug product shortages
(e.g., the ASHP17 and FDA18 drug shortages web resource
centers). The pharmacy should develop strategies for identi-
fying alternative therapies, working with suppliers, collabo-
rating with physicians and other health care providers, and
conducting an awareness campaign in the event of a drug
product shortage.19
Compounding. The home infusion pharmacist is responsible
for assuring appropriate techniques are used for preparing and
dispensing medications, following the home infusion phar-
macy’s policies and procedures and accepted standards of
practice. Double checks are a good practice in many steps of
the pharmacy dispensing process. The pharmacy should have
a process by which all high-risk calculations are checked for
accuracy by a second clinician. Pediatric medications (e.g.,
576  Practice Settings–Guidelines
doses), parenteral nutrition (PN), chemotherapy, pain man-
agement, and inotropes are examples of high-risk therapies.
It is also good practice that the pharmacist who processed
a new order should not be the same person who checks the
order for accuracy and completeness. In addition to double
checks on calculations, there should be visual double checks
on all medications listed as high-alert medications by the
Institute for Safe Medication Practices (ISMP) (e.g., heparin,
insulin, chemotherapy agents, PN additives).20
Compounding Sterile Preparations. Compounding of ster-
ile preparations should comply with applicable practice
standards, accreditation standards, and pertinent state and
federal laws and regulations. If these services are being pro-
vided by another pharmacy, the pharmacist should have rea-
sonable assurance that these standards are being met by the
pharmacy providing the service.21
Home infusion pharmacists are responsible for ensur-
ing the quality of sterile preparations intended for use in the
home. Guidance is available from various sources for devel-
oping an adequately designed and equipped facility, training
and validating employees, validating and documenting com-
pounding procedures, practicing aseptic technique, moni-
toring the work environment, maintaining the facility and
equipment, ensuring the quality of prepared preparations,
and developing policies and procedures.7,8
Stability and Compatibility Issues. Home infusion pharma-
cies are often required to assign extended beyond-use dates
to sterile preparations so that a multiple-day supply of medi-
cations can be dispensed and delivered. However, pharma-
cists should take into account circumstances that may affect
the medication’s potency and stability, including:
• Delivery of sterile preparations to the home, either by
the pharmacy’s own vehicles or by a common carrier;
• Storage of sterile preparations in the home before use;
• Manipulation of sterile preparations in the home envi-
ronment to add ingredients (such as vitamins) and to
set up tubing and filters for administration; and
• Administration of preparations at temperatures that
are warmer than controlled room temperature because
of administration in outdoor or non-air-conditioned
environments or the use of ambulatory infusion pumps
worn close to the body.
The home infusion pharmacist should consult USP Chapter
7978 and other appropriate resources to establish an appro-
priate beyond-use date. Applying published stability data
can introduce inaccuracies if the intended conditions of use
differ greatly from the reported conditions. Pharmacists
should maintain a record of the resources used for establish-
ing beyond-use dates. A table or chart of accepted beyond-
use dates, formulations, and conditions of use for commonly
prepared preparations may be helpful in ensuring that as-
signed dates are consistent and appropriate. Patients should
be trained to check preparations for current beyond-use
dates prior to their use.
Labeling. Medications for home use should be labeled so
that patients and caregivers can easily understand instruc-
tions for drug storage, preparation, and administration.
Auxiliary labels should be used as necessary. When ma-
nipulation of medications is required before administration,
labeling should clearly state current contents and the steps
for measuring, reconstituting, or adding other ingredients.
Labels for compounded medications should state the total
content of the medication or nutrient per container so that it
can be clearly known in case the patient is transferred to an-
other treatment setting. If medications are to be administered
with an infusion device, pump settings should be included
on the label. All labels shall conform to the requirements
of the law. Home infusion pharmacies should adopt the list
of prohibited abbreviations as another safety precaution to
ensure that patients and caregivers receive clear instructions
for drug use.
Packaging and Delivery. Policies and procedures should
be available to ensure product integrity and temperature
control during home delivery or patient pickup of supplies
and drugs. The pharmacist should ensure that the delivery
of medications and supplies to the patient occurs in a timely
manner to avoid interruptions in drug therapy. Furthermore,
the pharmacist should ensure that storage conditions dur-
ing delivery and while in the patient’s home are consistent
with the recommendations for storing the product and be-
yond-use dating. The temperature of home refrigerators or
freezers in which medications are stored should be within
acceptable limits and should be monitored by the patient or
caregiver. The pharmacist should ensure that an adequate
inventory of medications and ancillary supplies is available
in the patient’s home. It may be appropriate to provide addi-
tional inventory for unforeseen circumstances in which extra
doses or supplies may be required (e.g., waste, breakage, and
emergencies). The pharmacist is responsible for providing
sufficient quantities of medications and supplies to the pa-
tient, so that the ordered dosing regimen is maintained in the
home setting without missed doses due to lack of drugs or
supplies. Delivery to the patient should also include inven-
tory management to avoid excessive accumulation of sup-
plies and drugs. Excesses may indicate poor compliance,
inadequate patient training, failure to assess patient needs,
or ineffective inventory management by the patient. When
common carriers are used, the pharmacy is responsible for
ensuring that the carrier can provide timely delivery, proper
handling, and external temperature control. Delivery person-
nel should know the shipping requirements for each package.
If products are packaged so that product labels containing
storage instructions are concealed, an exterior label specify-
ing the storage conditions shall be used. To protect patient
confidentiality, prescription labels with medication names
and directions should not be used to label boxes. Box la-
bels should include only the patient’s name and address, the
storage requirements, and delivery instructions. Additional
precautions (i.e., double bagging, using at least one leak-
proof container, and cushioning) should be used to safeguard
hazardous products from breaking and leaking. The delivery
person, patient, and caregiver shall be trained to recognize
and manage accidental spills. Packages containing hazard-
ous products should have appropriate precautionary labels.
Products should be delivered in appropriate packaging
to ensure that labeled storage requirements are met during
transit under the expected environmental conditions. The
pharmacy should develop and follow written procedures
for packaging; these procedures should include privacy-
protection considerations. Product confirmation after deliv-

ery should be used to ensure that the packaging procedures
and materials used were effective in maintaining product
integrity and temperature control during transit. The stabil-
ity of refrigerated products at room temperature should be
taken into account in the development of packaging proce-
dures. A few refrigerated products have extended stability
at room temperature and may be safely delivered without
refrigerated packaging. Products that are stable for 24 hours
or less at room temperature should always be delivered in
temperature-controlled packaging (coolers, ice packs, etc.).
Hazardous Drugs. Policies and procedures for the defini-
tion, storing, handling, and disposing of hazardous drug
products should be available to ensure patient and employee
safety in compliance with applicable local, state, and federal
laws and regulations. Receipt, storage, and disposal of haz-
ardous substances shall comply with all applicable federal,
state, and local laws and regulations, including the Resource
Conservation and Recovery Act (RCRA), as well as applica-
ble guidance (e.g., ASHP guidelines,22 USP Chapter 7978).
Hazardous drug products should be stored in a negative
pressure compounding room whenever possible. Additional
storage precautions may include placement on a lower
shelf or containment in a resealable plastic bag. Employees
should be specially trained, and their handling and disposal
of these products should be monitored. Spill kits should be
available in locations where hazardous drugs are handled,
and all personnel who handle these agents should be trained
on using the kits.4,22
Controlled Substances. Policies and procedures for the stor-
age, distribution, use, and accountability of controlled sub-
stances should be available to ensure appropriate use and to
prevent diversion in compliance with applicable local, state,
and federal laws and regulations. Controlled substances
shall be kept in a secure and locked storage area that meets
the requirements of state law. Pharmacists should be aware
of the ways drugs can be diverted. Employees should be
carefully screened before hire. Processes should be in place
to minimize the risk of drug diversion and allow detection
should diversion occur. Policies or procedures for activities
such as ordering, receiving product, and conducting invento-
ries should assure proper supervision and limit opportunities
for a single individual to control the entire process.
Drug Samples. The use of drug samples should be elimi-
nated to the fullest extent possible. If samples are permitted,
the pharmacy should control these products to ensure proper
storage, records, labeling, and product integrity.
Patient Care
Pharmaceutical care, defined as the responsible provision of
drug therapy for the purpose of achieving definite outcomes
that improve a patient’s quality of life, has been adopted by
much of the pharmacy profession.23 The concept of pharma-
ceutical care is evolving into a more comprehensive, patient-
focused model of pharmacist-provided care, sometimes
termed pharmacist patient care. The principal elements of
such care are the same: it is medication related; it is care that
is directly provided to the patient; it is provided to produce
Practice Settings–Guidelines  577
definite outcomes; these outcomes are intended to improve
the patient’s quality of life; and the provider accepts personal
responsibility for the outcomes.23
The mission of the pharmacist is to help people make
the best use of medications. At a minimum, pharmacists are
responsible for assessing the legal and clinical appropriate-
ness of medication orders (or prescriptions), educating and
counseling patients on the use of their medications, monitor-
ing the effects of medication therapy, and maintaining pa-
tient profiles and other records. In the home infusion care
setting, these responsibilities are best accomplished through
the provision of pharmacist-provided patient care in which
pharmacists are responsible for establishing relationships
with patients and providers that will facilitate coordination
and continuity of care, improve access to care, and improve
patient outcomes.
Preadmission Assessment. The pharmacist, alone or in col-
laboration with other home infusion health care providers
(e.g., nurses), should ensure that each patient referred for
home infusion is assessed for appropriateness on the basis of
admission criteria, including the following:
• The patient, family, and caregiver agree with provision
of infusion services in the home;
• The patient or caregiver is willing and able to be edu-
cated about the correct administration of medications;
• The pharmacy can provide this education in a manner
that the patient, family and caregiver can understand;
• The home environment is conducive to the provision
of home infusion services (e.g., electricity and running
water are present, and the home is clean and safe);
• The home infusion provider has reasonable geographic
access to the patient;
• There is psychosocial and family support (e.g., care-
giver requirements and financial concerns are manage-
able, and the family environment is suitable);
• There is ongoing prescriber involvement in the assess-
ment and treatment of the patient;
• The medical condition and prescribed medication ther-
apy are suitable for home infusion services, and there
is a prognosis with clearly defined outcome goals;
• The indication, dosage, and route and method of ad-
ministration of medications are appropriate; and
• Appropriate laboratory tests are ordered for monitor-
ing the patient’s response to medications.
Using the information collected during the preadmission
assessment, the pharmacist, in conjunction with the other
health care providers involved in the patient’s care and the
patient or caregiver, will determine the patient’s appropri-
ateness for home infusion services. The conclusions of the
assessment should be communicated to all parties and ap-
propriately documented.
Initial Patient Database and Assessment. The complete pa-
tient database should be documented in the patient’s home
infusion record in a timely manner. This database should in-
clude, at a minimum, the following:
• The patient’s name, address, telephone number, and
date of birth;
578  Practice Settings–Guidelines
• The person to contact in the event of an emergency,
including the legal guardian or representative, if ap-
plicable;
• Information on the existence, content, and intent of an
advance directive, if applicable;
• The patient’s height, weight, and gender;
• All diagnoses;
• The location and type of termination site of the vas-
cular access device and internal and external catheter
lengths, if applicable;
• Pertinent laboratory test results;
• Pertinent medical history and physical findings;
• Nutrition screening test results;
• An accurate history of allergies;
• Initial and ongoing pharmaceutical assessments;
• A detailed medication profile, including all medica-
tions (prescription and nonprescription), immuniza-
tions, home remedies, and investigational and nontra-
ditional therapies;
• The prescriber’s name, address, and telephone num-
ber and any other pertinent information (e.g., Drug
Enforcement Administration number, National
Provider Identifier [NPI]);
• Other agencies and individuals involved in the
patient’s care and directions for contacting them;
• A history of medication use; and
• A care plan and a list of drug-related problems, if any.
To obtain this information, the pharmacist could use the
medical record; laboratory test results; direct communica-
tion with the patient, caregiver, nurse, and prescriber; and
direct observation. When the pharmacist cannot directly ob-
serve the patient, the patient’s home infusion nurse or other
appropriate health care provider could provide the results
of direct observation and physical assessment. If a shared-
service agreement exists among multiple providers, the
pharmacist should ensure that this agreement specifies the
responsibilities of each provider for obtaining and sharing
pertinent patient information.
Medication Reconciliation. Pharmacists should prepare or
have access to comprehensive medication histories for each
patient, including prescription drugs, nonprescription drugs,
and alternative therapies. A pharmacist-conducted medica-
tion history for each patient is desirable; however, another
appropriate health care provider (e.g., home infusion nurse,
pharmacy technician) may obtain and maintain current med-
ication histories, provided this information is accessible to
the pharmacist and other health care providers.
Development of Care Plans. The pharmacist, in collabo-
ration with the patient or caregiver and other health care
providers, is responsible for developing an appropriate and
individualized care plan for each patient. The pharmacist’s
contribution to the care plan should be based on informa-
tion obtained from the initial pharmacy assessment and other
relevant information obtained from the nurse, prescriber, pa-
tient, and caregivers. At a minimum, the pharmacist’s contri-
bution to the care plan should include the following:
• A description of actual or potential drug therapy prob-
lems and their proposed solutions;
• A description of desired outcomes of the drug therapy
provided;
• A proposal for patient education and counseling; and
• A plan specifying proactive objective and subjective
monitoring (e.g., vital signs, laboratory tests, physical
findings, patient response, toxicity, adverse reactions,
and noncompliance) and the frequency with which
monitoring is to occur.
The care plan should be developed at the start of therapy
and regularly reviewed and updated; the degree of detail of
the plan should be based on the complexity of drug therapy
and the patient’s condition. Updates or changes to the plan,
as they occur, should be communicated to other health care
providers involved in the patient’s care, to the patient, and to
caregivers. The care plan and updates should be a part of the
patient’s record.
Clinical Monitoring. The pharmacist is responsible, in col-
laboration with other health care providers, for ongoing
clinical monitoring of the patient’s drug therapy according
to the care plan and for appropriately documenting and com-
municating the results of all pertinent monitoring activities
to other health care providers involved in the patient’s care.
The pharmacist is also responsible for ensuring that relevant
information is obtained from the patient, the caregiver, and
other health care providers and for documenting this infor-
mation in the patient’s home infusion record.
Pharmacists may, in collaboration with prescribers
and others, wish to develop clinical monitoring protocols
for various therapies that could be individualized in specific
care plans. Pharmacists may receive laboratory test results
before other health care providers. In such cases, the phar-
macist is responsible for communicating the test results to
the prescriber and other health care providers. The pharma-
cist should provide an interpretive analysis of the informa-
tion and recommendations for dosage adjustments and for
continuation or discontinuation of drug therapy. The phar-
macist should ensure that sufficient laboratory test results
are readily available for monitoring the patient’s therapy. In
shared-service arrangements, clinical monitoring responsi-
bilities should be delineated.
The patient, the family, the caregiver, and all health
care providers involved in the patient’s care should have
access to a pharmacist 24 hours a day. The pharmacist is
responsible for providing a summary of all relevant clinical
information to another pharmacist providing coverage for
that patient (e.g., an on-call pharmacist) before transferring
patient care responsibilities.
Patient Consultation and Education. Home infusion phar-
macists will primarily consult patients or caregivers over
the telephone. Home visits should be considered for en-
hancing compliance or simplifying complex drug-related
patient issues.
The home infusion pharmacist, or the home infusion
nurse as the agent, should ensure that the patient, caregiver,
and other health care providers understand the proper use
and administration of medications provided, including vas-
cular access and infusion devices, as required. The home in-
fusion pharmacist, or the nurse as the agent, should explain
to the patient or the patient’s agent the directions for use and
any additional information.

The pharmacist is responsible for ensuring that the pa-
tient or caregiver receives appropriate education and coun-
seling about the patient’s medication therapy.24 The pharma-
cist should verify that the patient or caregiver understands
the therapy. Other health care providers may be involved in
the education and counseling. A home infusion pharmacist
should be readily accessible if questions or problems arise.
Supplementary written information should be provided to
reinforce oral communications. Contingencies should be
available to provide education, counseling, and written ma-
terials to patients whose understanding of English may be
compromised. Depending on the need, this might require ac-
cess to interpreters or bilingual pharmacists. Patients who
have hearing and sight impairments will potentially need
other support or communication resources.
Professional judgment is required to determine what
information should be included in patient education and
counseling. The following should be considered:
• A description of medication therapy, including drug,
dose, route of administration, dosage interval, and du-
ration of therapy;
• The goals of medication therapy and indicators of
progress toward those goals;
• Self-assessment techniques for monitoring the effec-
tiveness of therapy;
• The importance of following the therapeutic plan;
• Proper aseptic technique;
• Hand hygiene;
• Proper care of the vascular-access device and site, if
applicable;
• Precautions and directions for administering medica-
tions;
• Inspection of medications, containers, and supplies
prior to use;
• Equipment use, maintenance, and troubleshooting;
• Home inventory management and procedures for
securing additional supplies and medications when
needed;
• Potential adverse effects, drug–drug interactions,
drug–nutrient interactions, contraindications, adverse
reactions, and the management of those events;
• Special precautions and directions for the preparation,
storage, handling, and disposal of drugs, supplies, and
biomedical waste;
• Information on contacting health care providers in-
volved in the patient’s care;
• Examples of situations that should be brought to the at-
tention of the pharmacist or other health care providers
involved in the patient’s care (e.g., missed doses, doses
not given at the proper time, and low supplies); and
• Emergency procedures.
Patient counseling and education should be performed in ac-
cordance with applicable state regulations and documented
in the patient’s home infusion record.
Communication with Patients and Caregivers. Effective
communication among pharmacists, patients, and caregiv-
ers is also essential to ensuring high-quality care. The phar-
macist providing home infusion services should establish
free and open channels of communication with patients and
Practice Settings–Guidelines  579
caregivers. The pharmacist should contact the patient or the
caregiver, as appropriate, to
• Obtain information needed for the initial pharmacy as-
sessment;
• Provide supplemental patient education and counsel-
ing as needed;
• Assess compliance with drug therapy;
• Assess progress toward the goal of therapy;
• Inform the patient how to contact the pharmacist when
needed; and
• Assess drug therapy problems (e.g., failure to respond
to therapy and adverse drug events).
All contacts with the patient should be documented in the
patient’s home infusion record.
Communication with Physicians, Prescribers, Nurses, and
Other Health Care Providers. Effective communication
among pharmacists and other health care providers is essen-
tial to ensuring continuous, coordinated care. The pharma-
cist should ensure that effective channels of communication
about care are in place, including shared-service arrange-
ments (e.g., regarding pain assessments and laboratory test
data). Oral and written communication methods can be used
for communicating patient information. All relevant clinical
communication should be documented in the patient’s home
infusion record. The pharmacist is responsible for protecting
the patient’s privacy and confidentiality while communicat-
ing this information to other health care providers. Personnel
involved in the care of the patient should meet regularly to
discuss the clinical status of the patient and any operational
issues related to the patient’s care.
Medication Administration. Policies and procedures on the
administration of medications should be available. Only per-
sonnel who are authorized by the home infusion organization
and are appropriately trained and licensed should be per-
mitted to administer medications to a patient. Pharmacists,
where legally permitted, may be authorized to administer
medications after receiving appropriate training.
Emergency Medical Care. The home infusion pharmacist
should participate in decisions about the emergency care of
patients at home, including the development of protocols
for using emergency drugs in the home. Policies and proce-
dures should exist within the organization for providing ap-
propriate levels of patient care during emergency situations
24 hours a day, including access to the pharmacist respon-
sible for the care, when appropriate. Appropriately trained
pharmacists should have an authorized role in responding
to medical emergencies. The pharmacy should participate in
the development of policies and procedures to ensure avail-
ability of, access to, and security of emergency medications.
Discharge from Home Infusion. When patients have com-
pleted therapy as ordered, they should be discharged from
service. Items that should be documented in the medical
record upon discharge include the patient’s response to
therapy and status at discharge.
580  Practice Settings–Guidelines
Transfer to Another Care Setting. The pharmacist should en-
sure continuity of pharmacist care to and from the home and
other patient-care settings. The pharmacist should routinely
contribute to processes ensuring that each patient receives
pharmacist care regardless of transitions that occur across
different health care settings (for example, among different
components of a health system and different types of home
infusion services). When home infusion patients are admit-
ted to a hospital, the home infusion pharmacy should inform
the hospital about (1) the medications the patient is currently
receiving from the home infusion pharmacy and (2) known
allergies. The home infusion pharmacy should recognize hos-
pital policy when considering whether properly stored medi-
cations and medical equipment from the home can be used
during the home infusion patient’s hospitalization.
Documentation in the Home Infusion Medical Record.
Clinical actions and recommendations by pharmacists that
are intended to ensure safe and effective use of medications
and that have a potential effect on patient outcomes should
be documented in patients’ home infusion medical records.
Pharmacists should provide oral or written consultations
to other health professionals regarding medication therapy
selection and management. Consultations should be docu-
mented in the patient’s home infusion medical record. The
pharmacy should have an ongoing process for consistent
documentation (and reporting to physicians, administrators,
and others) of pharmacist care and patient outcomes resulting
from medication therapy and other pharmacy actions. Patient
privacy and confidentiality should be protected at all times.
A home infusion record should be developed and
used for documenting the home infusion services provided
to each patient. Written organizational policies and proce-
dures should address the security of home infusion records
and specify personnel authorized to review patient records
and to make entries. The need to maintain confidentiality
of patient information should be stressed to all personnel.
The pharmacist is responsible for documenting all pharmacy
clinical activities in the patient’s record in a timely manner.
General clinician-oriented forms are preferred over specific
nursing, pharmacy, and other health care professional forms
to minimize duplication of information. It may be advis-
able for organizations that provide multiple home infusion
services (e.g., pharmacy, nursing, respiratory therapy, dieti-
cians) to use a single home infusion record for documenting
all clinical information regarding each patient. The patient’s
record should be accessible at all times to authorized person-
nel involved in the care of the patient, but confidentiality
should be maintained.
Selection of Products, Devices, and Ancillary Supplies. The
pharmacist, in collaboration with other health care provid-
ers and the patient, is responsible for selecting infusion de-
vices, ancillary drugs (e.g., heparin lock flush solution, 0.9%
sodium chloride flush), and ancillary supplies (e.g., dressing
kits, syringes, and administration sets). Pharmacists should
be thoroughly trained and knowledgeable in the selection,
proper use, and maintenance of these devices, drugs, and
supplies. Factors involved in the selection of devices and
ancillary supplies may include the following:
• The stability and compatibility of prescribed medica-
tions in infusion device reservoirs;
• The ability of an infusion device to accommodate the
appropriate volume of medication and diluent, and to
deliver the prescribed dose at the appropriate rate;
• The ability of the patient or caregiver to learn to oper-
ate an infusion device;
• The potential for patient complications and noncom-
pliance;
• Patient preference;
• Nursing or caregiver experience with therapies and
selected devices;
• Prescriber preferences;
• Cost considerations; and
• The safety features of infusion devices.
Patient’s Own Medications. Drug products and related de-
vices not dispensed by the home infusion pharmacy that are
to be used during the patient’s course of therapy should be
documented in the patient’s home infusion medical record.
When home infusion patients are known to be admitted to a
hospital or other extended care facility, the home infusion
pharmacy should inform the hospital about the medications
the patient is currently receiving from the home infusion
pharmacy and about any known allergies. The home infu-
sion pharmacy should recognize hospital policy when con-
sidering whether properly stored medications and medical
equipment from the home can be used during the home infu-
sion patient’s hospitalization.
Emergency Medications. The home infusion pharmacist,
in consultation with the prescriber, should determine when
emergency medications and supplies (e.g., anaphylaxis
“kits”) should be dispensed to home infusion patients. When
standing orders for ancillary drugs or supplies or standardized
treatment protocols are used, the pharmacist should review
each protocol to determine its appropriateness for the patient.
Performance Improvement Activities
The home infusion pharmacy should have an ongoing, sys-
tematic program for assessing pharmacist patient care, and
pharmacists should be active participants in performance
improvement activities. A performance improvement pro-
gram for home infusion should monitor patient satisfaction
and outcomes, and the program should also include appro-
priate quality control measures for compounding sterile
preparations and other activities. Performance improvement
activities based on assessments should be integrated with the
health system’s overall performance improvement activities,
as applicable. The performance improvement team should
work with frontline staff to implement systems that include
proper checks and balances focused on protecting against
human error. Performance improvement initiatives should
be focused on error reporting trends and high-risk functions
such as dispensing high-alert medications.
Benchmarking. As part of the performance improvement
program, operational and outcomes data should be bench-
marked with those of other home infusion pharmacy ser-
vices of similar size and scope. The results, including fol-
low-up actions for improvement, should be documented and
provided to the organization’s managers, the frontline staff
using the system, and others as appropriate.

Clinical Outcomes. Most accrediting bodies and some regu-
latory agencies require the home infusion pharmacy to mon-
itor clinical patient outcomes. Common measures that are
tracked routinely by home infusion companies include the
rate of catheter-related infections, adverse drug reactions,
medication errors, warehouse/delivery errors, equipment
malfunctions, and unplanned hospitalizations. In addition,
the organization should have an infection control program
in which both staff and patient infection (communicable dis-
eases) rates are monitored. The organization may also select
outcomes that are monitored over a short time as a specific
process is improved.
Medication Error Reporting. Medication error monitoring
and prevention should be part of every pharmacy’s perfor-
mance improvement program. Information about strate-
gies to prevent medication errors is available from several
sources, including ISMP, which produces regular newslet-
ters on this topic.
All pharmacies should have processes in place that
are designed to prevent and detect medication errors before
they leave the pharmacy. If an error does occur, the phar-
macy director and staff should determine how and why the
error happened, and what can be done to prevent similar er-
rors from occurring. Medication errors should be reported
to voluntary national reporting systems and, as required, to
accrediting organizations or regulatory agencies. Reports
should be documented, analyzed, trended and reviewed con-
sistent with National Coordinating Council for Medication
Error Reporting and Prevention (NCCMERP) standards.
Patient Satisfaction. Most accrediting bodies require the
home infusion pharmacy to measure patient satisfaction
with treatment and services. This function can be performed
in-house by mailing questionnaires to the patient, or it can be
outsourced to a contractor. Patient satisfaction surveys that
are returned should be reviewed for both positive and nega-
tive comments so that corrective action can be targeted to
service issues.
Medication-Use Evaluation. An ongoing program of moni-
toring drug utilization and costs should be in place to ensure
that medications are used appropriately, safely, and effec-
tively, and to increase the probability of desired outcomes
within defined populations of patients. The medication-use
policy committee should define specific parameters for eval-
uation (e.g., disease state, pharmacologic category, high-use/
high-cost drug products, high-alert medications) as appro-
priate for the organization. Through this ongoing evaluation,
areas in need of improvement in medication prescribing and
management can be identified and targeted for intervention.
Adverse Drug Event Reporting. The home infusion phar-
macist should take a leadership role in the development of
a program for reporting and monitoring all adverse drug
events and device-related events, including adverse drug
reactions and medication errors. The pharmacist should en-
sure that the prescriber is notified promptly of any suspected
adverse drug events. Adverse drug events should serve as
outcome indicators of quality, and the monitoring of adverse
drug events should be a part of the organization’s ongoing
performance improvement program. Relevant trends should
be integrated into staff development and in-service education
Practice Settings–Guidelines  581
programs for pharmacists and nurses to improve the quality
of care and patient outcomes. Serious adverse drug reactions
and device-related problems should be reported promptly to
the manufacturer and to the Food and Drug Administration’s
MedWatch program.25
Operations
Hours of Operation. Home infusion pharmacy services shall
be available 24 hours a day, seven days a week. A pharma-
cist should be available for consultation or dispensing after
hours. Home infusion pharmacy staff may be supplemented
by knowledgeable and experienced part-time or on-call per-
sonnel to extend pharmacy services coverage.
Pharmacy Security and After-Hours Access. Only autho-
rized pharmacy personnel should have access to the phar-
macy area. Other home infusion organization personnel may
be in the pharmacy area only when an authorized pharmacist
is present, in accordance with the home infusion organiza-
tion’s policies or as required by laws and regulations. In an
emergency situation in which a pharmacist is not present,
such as a fire or security alarm, policies and procedures
should guide safe access to the pharmacy area and provide
for notification of the pharmacist in charge or a designee.
Emergency Preparedness and Business Continuity
Planning. Policies and procedures should be available that
include a plan for providing pharmacy services in case of
an area-wide disaster affecting the home infusion pharmacy
or patients’ home infusion settings. Appropriately trained
pharmacists and representatives from the pharmacy team
should be members of emergency preparedness teams and
participate in drills. Patients should be informed about what
to do to safely continue needed home therapies in the event
of a disaster. The health system’s business continuity plan
should address the provision of pharmacy services in non-
emergency situations, such as information system failures or
disruptions of the drug procurement process.19,26
Communications. Staff meetings should be conducted on a
regular basis for various purposes, which may include:
• Brief daily meeting to review on-call issues, upcoming
referrals, and current daily plan;
• Hand-off communications to and from evening staff or
on-call personnel;
• In-services regarding updates to policies or proce-
dures, law, regulation, or services;
• Review of new medications;
• Analysis of sales and marketing efforts;
• Performance improvement functions;
• Team building among the staff; or
• Interdisciplinary meetings or case conferences to com-
municate the pharmacist’s care plan for a patient (with
patients, caregivers, physicians, prescribers, or other
health professionals).
Equipment Management. Equipment may be owned, leased,
or rented by the infusion pharmacy. It is usually most cost-ef-
fective to lease-purchase infusion pumps that are used in high
volume. Pumps with specialized uses (e.g., micro-infusers)
may be used less frequently and may be rented as needed.
582  Practice Settings–Guidelines
Equipment may be purchased or rented from a properly quali-
fied vendor. Routine maintenance (i.e., basic safety checks,
alarm testing, and accuracy validation) is performed between
patient use, and preventive maintenance for medical equip-
ment is defined by the manufacturer for each specific device.
The manufacturer’s preventive maintenance recommenda-
tions should be followed, and all equipment should be main-
tained so that the preventive maintenance is not overdue dur-
ing patient use. Technical repair of medical equipment should
be done by a properly qualified service technician. Home
infusion pharmacies typically do not have the capacity to
employ staff on site with the technical certification required
for equipment preventive maintenance or repair. Outsourcing
these functions is usually the most efficient and cost-effective
way to maintain equipment in good working order.
Records Storage and Maintenance. Adequate space should
be available for maintaining and storing records, including
medication profiles and other patient information, man-
agement information, equipment maintenance sheets, con-
trolled-substances inventory sheets, and MSDSes, among
others, to ensure compliance with laws, regulations, ac-
creditation requirements, and sound management practices.
Patient records shall be secure. Records shall be retained ac-
cording to applicable laws and regulations, which may vary
by state and by Centers for Medicare & Medicaid Services
(CMS) participation guidelines. There may be additional re-
cord retention requirements for specific patient population
(e.g., pediatric patients) medical records in some states and
according to accreditation standards.
Information Technology. Computer resources should be
used to maintain patient medication profiles, perform nec-
essary patient billing procedures, manage drug product in-
ventories, and interface with other available computerized
systems to obtain patient-specific clinical information for
drug therapy monitoring and other clinical functions and to
facilitate the continuity of care after patients transfer to and
from other care settings.
Home Infusion Medical Record Systems. A patient medi-
cation profile should be maintained by all home infusion
pharmacies regardless of where the dispensing of medica-
tions takes place. The home infusion medical record should
include assessment and care planning documents, progress
notes, laboratory test results, and other patient information
related to determining the appropriateness of medications
and monitoring their effects. The system should provide
safeguards against the improper manipulation or alteration
of records and provide an audit trail.
An automated information system is preferred, but
the system may be manual, automated, or a combination
of the two. If an automated information system is used, an
auxiliary record-keeping procedure should be available for
documenting medication information in case the automated
system is inoperative, and a daily data backup system should
be in place.
Hazardous Waste Management and Disposal. There are
many ways to dispose of hazardous waste generated by the
pharmacy. In addition to the established waste management
companies, there are also mail-back services. For the tra-
ditional services, it is important to follow the company’s
requirements. Since much of the waste eventually is sent
to dump sites, waste that needs to be incinerated should be
discarded separately. The companies that provide mail-back
service also incinerate all the waste they receive, so it is
not necessary to separate the waste. It is also important that
the pharmacist understand the OSHA and RCRA require-
ments regarding management and disposal of hazardous
substances. There should be a designated area for hazardous
waste, including sharps. Spill kits should be readily avail-
able in locations where hazardous substances are handled,
and all personnel who handle these agents should be trained
on using these kits.4,22
Facilities
To ensure optimal operational performance and quality pa-
tient care, adequate space, equipment, and supplies should
be available for all professional and administrative func-
tions related to medication use. These resources should be
located in areas that facilitate the provision of services to
patients, nurses, prescribers, and other health care providers
and should be integrated with the home infusion organiza-
tion’s communications, delivery, or transportation systems.
Facilities should be constructed, arranged, and equipped to
promote safe and efficient work and to avoid damage to or
deterioration of drug products.
Ambulatory Infusion Center or Infusion Suite. Pharmacies
that have an on-site (ambulatory) infusion suite must in-
clude appropriate access to the facility (e.g., handicapped
parking, sidewalk ramp) and other internal design features
(e.g., restroom grab bar) according to the Americans with
Disabilities Act. Local building code regulations may also
apply. Accreditation standards for home care organizations
typically include a section on infusion suites and cover such
items as patient access, facility safety checks, nursing pro-
cedures, and room sanitation. State and local authorities
may have additional regulations for ambulatory treatment
centers; these should be researched before planning to offer
ambulatory treatment services.
Home Infusion Pharmacies. Designated space and equip-
ment for compounding and packaging sterile preparations
should be available.7,8 The compounding environment
should be monitored and maintained on an ongoing basis.
Appropriate facility space, equipment, and supplies for com-
pounding hazardous preparations should be available.7,8,22
Adequate facilities and equipment should be established
for decontaminating, cleaning, and maintaining infusion de-
vices, including durable medical equipment.
General Work Area. The pharmacy work area should allow
pharmacists to observe work being done by support staff
(telephone calls to patients, computer data entry, compound-
ing, etc.). Pharmacies should consider having an area dedi-
cated to the function of checking compounded preparations
and other prescriptions that is out of the main traffic pat-
tern and where the checking pharmacist is not distracted by
noise, telephones, or conversation.
Stockroom and Storage Areas. Facilities should be avail-
able for storing and preparing medications in the home
infusion pharmacy under proper conditions of sanitation,

temperature, light, moisture, ventilation, segregation, and
security to ensure medication integrity and personnel safety
and to prevent drug diversion.27 Adequate refrigeration and
freezer capacity should be provided within the secure phar-
macy area.
Office and Meeting Space. Office and meeting areas should
be available for administrative, clinical, technical, and re-
imbursement staff. Ideally, interdisciplinary team members
from pharmacy, nursing, and reimbursement are located
within a proximate space.
Cleanroom and Anteroom (Compounding Area). The home
infusion pharmacy should follow all applicable federal,
state, and local requirements, including USP Chapter 797,8
for building and maintaining the pharmacy’s compound-
ing facilities. Options for building out a cleanroom include
purchase of a modular prefabricated unit or building out an
existing space with only those materials needed to bring the
facility into compliance with laws, regulation, and guidance.
Design and organization of the cleanroom should allow for
the pharmacist’s view of compounding activities through a
large window or clear wall and efficient flow of materials and
compounding documents into the cleanroom for processing
and out of the cleanroom for the checking/verification step.
Sterile medications shall be compounded within a pri-
mary engineering control such as a laminar flow hood or
a compounding aseptic containment isolator. Compounding
facilities shall be cleaned and maintained following fed-
eral, state, and local laws or regulations as well as appli-
cable guidance (e.g., ASHP guidelines, USP Chapter 797).7,8
Environmental monitoring of the compounding facilities
shall be ongoing and should include all elements required
by federal, state, and local laws or regulations as well as
applicable guidance (e.g., ASHP guidelines, USP 797).7,8
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Approved by the ASHP Board of Directors on June 28, 2013.
Developed through the ASHP Section of Ambulatory Care
Practitioners Section Advisory Group on Home Infusion. These
guidelines supersede the ASHP Guidelines on the Pharmacist’s
Role in Home Care dated April 27, 2000, and the ASHP Guidelines:
Minimum Standard for Home Care Pharmacies dated November 14,
1998.
Barbara J. Petroff, M.S., FASHP; Donald Filibeck, Pharm.D.,
M.B.A.; Anna Nowobilski-Vasilios, Pharm.D., M.B.A., CNSC,
BCNSP, FASHP; R. Stephen Olsen, Pharm.D.; Carol J. Rollins,
Pharm.D., M.S., RD, BCNSP; and Cathy Johnson, B.S.Pharm., are
gratefully acknowledged for authoring these guidelines.
ASHP gratefully acknowledges the contributions of the following
individuals to these guidelines: Mitra Gavgani, Pharm.D.; Brian
G. Swift, Pharm.D., M.B.A.; Lisa Linn Siefert, B.S.Pharm., ASQ-
CQM, FASHP; Kelly Rogers, B.S.Pharm.; and Caryn M. Bing,
M.S., FASHP.
ASHP also gratefully acknowledges the following organizations
and individuals for reviewing these guidelines (review does not im-
ply endorsement): Academy of Managed Care Pharmacy (AMCP);
American Academy of Ambulatory Care Nursing (AAACN);
American Society for Parenteral and Enteral Nutrition (ASPEN);
Infusion Nurses Society; Rhode Island Society of Health-System
Pharmacists; Jeanette Spain Adams, Ph.D., RN, ACNS, BC, CRNI;
Mary Alexander, M.A., RN, CRNI, CAE, FAAN; Dominick A.
Caselnova III, B.S.Pharm., M.H.A., FASHP; Toby Clark, M.Sc.,
FASHP; Sharon M. Durfee, B.S.Pharm., BCNSP; Michael Edwards,
Pharm.D., M.B.A., BCOP, FASHP; Allen Flynn, Pharm.D.,
CPHIMS, CHS; Peggi Guenter, Ph.D., RN, CNSN (ASPEN);
Kathleen M. Gura, Pharm.D., BCNSP, FASHP, FPPAG; Richelle
Hamblin, RN, M.S.N., CRNI (AAACN); John Hertig, Pharm.D.,
M.S.; Tim Lanese, M.B.A., FASHP; Jay Lewandowski, Pharm.D.;
Mary R. Monk-Tutor, Ph.D., FASHP; Richard D. Paoletti, M.B.A.,
FASHP; Susan M. Paschke, M.S.N., RN-BC, NEA-BC (AAACN);
Stephanie Peshek, Pharm.D., M.B.A., FASHP; Nicole Pilch,
Pharm.D., MSCR, BCPS; James A. Ponto, M.S., BCNP, FASHP;
Tony Powers, Pharm.D.; Curt W. Quap, M.S., FASHP; Armando
Riggi, Pharm.D.; Jean S. Rutledge, Ph.D.; Elizabeth Sampsel,
Pharm.D., M.B.A., BCPS (AMCP); Robert A. Smaglia, B.S.Pharm.;
Nancy R. Smestad, M.S.; Rex Speerhas, CDE, BCNSP; Melisa
Tong, Pharm.D.; and Kristine Widboom.
Copyright © 2014, American Society of Health-System Pharmacists,
Inc. All rights reserved.
The bibliographic citation for this document is as follows: American
Society of Health-System Pharmacists. ASHP Guidelines on Home
Infusion Pharmacy Services. Am J Health-Syst Pharm. 2014;
71:325–41.